IEC 60601-1-2

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Body

IEC

Number

IEC 60601-1-2

Editions

2014、2020

FDA recognition no.

19-36

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: 1. Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT. 2. Subclause 8.9, Table 8 on Page 39: The citation of Note k) under "Conducted disturbances induced by RF fields" (4th Row).

Scope source: FDA 认可共识标准库

Laboratories covering this standard